Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04102813 |
| Other study ID # |
06/2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 24, 2020 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The exposure to acute and\or chronic stress can produce an activation of sympathetic nervous
system (SNS), leading to an increased level of cortisol and pro-inflammatory cytokines. The
mind-body techniques (MBT), such as diaphragmatic breathing, mindfulness, and Yoga, have
demonstrated their validity in reducing mental stress and relieving inflammatory conditions.
The aim of our study is to verify the efficacy of a single Functional Therapy (FT) session to
relieve inflammations, decreasing cortisol levels and activating the parasympathetic nervous
system in healthy subjects after the administration of an acute stress such as the Trier
Social Stress Test (TSST) protocol. After a psychiatric, psychological and anthropometric
assessment, participants are randomly assigned to FT or attention placebo control group. The
FT session lasting for 30 minutes and is conducted by therapists specialized in the MBT. The
treatment's efficacy in reducing inflammatory states is verified by measuring the variations
of the hearth rate, skin conductance, electromyography, pro-inflammatory cytokines (IL-6,
TNFα, IL1β), anti-inflammatory cytokine (IL-10), and salivary cortisol; furthermore, the
State Trait Anxiety Inventory (STAI) (state and trait) and Subjective Units of Distress Scale
(SUDS) questionnaires are used as psychometric measures of anxiety and stress. All the
participants are tested at baseline, at the end of TSST, at the end of the FT or audiobook
session, and at follow-up 30 minutes after the session.
Description:
Life's dynamics in modern societies expose the individuals to high level of suffering and
stress, which can affect both psychological and physiological well-being. Numerous scientific
evidences showed the correlation between stress and immunity system dysregulation. The
exposure to acute and\or chronic mental stress conditions can alter the physiological
functions of the organism, through the activation of sympathetic nervous system (SNS) and the
inhibition of the parasympathetic nervous system (PNS). The activation of peripheral and
central immune-inflammatory pathways is indicated by increased levels of proinflammatory
cytokines, such as Interleukin-1 β (IL-1β), Interleukin-6 (IL-6), and Tumor necrosis factor-α
(TNFα). Furthermore, experiencing high stress levels may lead to a disruption of the
Hypothalamic-Pituitary-Adrenal (HPA) axis, with consequent increasing of cortisol's level,
low-grade systemic inflammation and oxidative stress. These results correlate with the
develop and progression of a wide range of pathological conditions, such as cardiovascular
disease, Type II diabetes, arthritis, osteoporosis, Alzheimer's disease, and depression. In
addition, inflammation is now considered as a risk factor for most cancers' disease,
promoting pathological mechanism such as proliferation, angiogenesis and metastases.
The last 20 years has seen an exponential growth of the mind-body techniques (MBT), an
heterogeneous group of exercises and techniques focusing the life-styles, which has
demonstrated validity in the reduction of psychological stress and inflammatory states. The
techniques adopted by the clinical trials available include Yoga, Mindfulness, Tai Chi Chih,
and Qigong; these protocols last usually from 4 to 12 weeks, and have been applied on
clinical samples ranging on heterogeneous pathological conditions. However, the techniques
used in the majority of these studies are derived from eastern meditative tradition and were
not primarily developed to carrying out anti-inflammatory effects. Furthermore, the data
concerning the effects of a single session of MBT under controlled experimental conditions
are still lacking. In this regard, the Functional Therapy (FT) approach, an integrated
body-mind therapy developed around the knowledges of psychoneuroimmunology (PNI), represents
a potentially effective and specific methodology to counteract the physiological and
psychological effects caused by prolonged exposure to stress conditions.
Given these premises, the aim of this clinical trial is to verify the efficacy of a single
Functional Therapy (FT) session to relieve inflammations, decreasing cortisol levels and
activating the parasympathetic nervous system in healthy subjects after the administration of
an acute stress such as the Trier Social Stress Test (TSST).
Patients will be recruited starting in October 2019, via advertisement posted in university
classrooms and premises. Researchers planned to recruit a sample of 40 participants. For the
recruitment a structured telephone screening will help the researchers to investigate on some
exclusion criteria. Then a consultation with a clinical psychologist and a psychiatrist will
be programmed together with the administration of the psychological tests. Psychological
assessment includes an ad-hoc sociodemographic questionnaire; a shortened version of Wechsler
Adult Intelligence Scale - Revised (WAIS-R); Millon Clinical Multiaxial Inventory-III
(MCMI-III); and Stress-related Vulnerability Scale (SVS). All these assessments will take
place in the outpatient clinic of the policlinic "P. Giaccone", Palermo. After the
assessment, eligible subjects will be randomized in the FT group or in the attention control
group (AC), and will be assigned to the next therapist on a time capacity list.
All the sessions will be taking place in the Neo-Functional Psychotherapy Centre of Palermo.
During the session, participants will be assessed for anthropometric, psychological,
biofeedback and salivary parameters. Anthropometric parameters include height, weight, and
BMI; Psychological assessment includes the State-Trait Anxiety Inventory, in both trait and
state form; and Subjective Unit of Distress Scale. Biofeedback parameters include hearth
rate, skin conductance, and electromyography. Salivary measurements include pro-inflammatory
cytokines (IL-6, TNFα, IL1β), anti-inflammatory cytokine (IL-10), and cortisol.
Upon arrival, the anthropometric parameters will be assessed, thus biofeedback sensors will
be connected to participants and it will record, for 5 minutes, the physiological parameters
that will constitute the baseline; biofeedback sensors will remain online for the whole
duration of the clinical trial. During this phase the STAI (trait and state) and SUDS
questionnaires will be administered, and the first salivary samples will be taken for
cortisol and cytokines.
Then, participants will be submitted to the TSST social stress, a protocol used by
researchers to induce stress under controlled condition. TSST is divided in 5 minutes
components and the whole procedure lasts approximately 15 minutes; at the end, the second
psychological and salivary assessments will be carried out.
Participants will be randomized in FT group or AC group. Five different therapists with a
4-year postgraduate training on functional approach will apply the FT session. The treatment
was specifically manualized to reducing stress condition and to relieve inflammatory states.
Specifically, the treatment includes a variety of functional techniques such as diaphragmatic
breathing, and thoracic and abdominal manipulation, designed to stimulate the neurofunctional
interconnection between body, mind and immune system. The FT session will last 30 minutes.
The participants assigned to the AC will listen an audiobook lasting for 30 minutes, which
will be used as attention placebo control activity. At the end of the session, the third
psychological and salivary assessments will be carried out.
Finally, all the participants will be undergoing to a follow-up phase, designed to assess the
biofeedback and cytokines slow-responses to stress and relaxation procedures. Thus, subjects
will be provided with an additionally 30 minutes session of audiobook listening, used as
attention control placebo. At the end of the session, the fourth psychological and salivary
assessments will be carried out.
